Post-Market Obligations AMDD compliance would also entail more robust post-marketing requirements f

Post-Market Obligations
AMDD compliance would also entail more robust post-marketing requirements for device manufacturers throughout all ASEAN member states. As part of a proposed Post Marketing Alert System (PMAS) that all ASEAN member states would implement, manufacturers would need to maintain distribution and complaint records to improve traceability. Mandatory reporting of adverse events by medical device dealers and healthcare providers is also required under the proposed PMAS, as well as Field Safety Corrective Actions (FSCA, a synonym for recall) in instances where a product owner must take steps to reduce or eliminate risks posed by its device.

Specific PMAS requirements that manufacturers and/or their authorized representatives would have to meet include:

• Distribution records: Manufacturers, authorized representatives and distributors must establish and set up procedures for maintaining distribution records, and keep distribution records for each medical device they market. Information such as initial consignee’s name and address, identification and quantity of device shipped, and control numbers of devices shipped should be included in such records;
• Complaint records: Medical device firms and their representatives must keep records of complaints issued against their products; all communications, evaluations and corrective actions must be included in these records. Manufacturers, representatives and distributors must also have written policies in place for complaint handling;
• Adverse events: The AMDD would require reporting of adverse events based on three criteria— that an adverse event has occurred, the medical device associated with the adverse event, and if the adverse event has led to a public health threat, patient death or injury. Adverse event reporting requirements would apply to manufacturers, representatives and distributors; and
• FSCA: Device product owners bear responsibility for deciding whether FSCAs are appropriate, according to the AMDD. Risk assessments compliant with ISO 14971, current version, should be used in such determinations. If a product owner or representative decides to initiate a FSCA, appropriate market regulators must be notified.